Common Commentary on Paediatric Oncology Drug Development Published: Another Step in Optimising Global Regulatory Coordination of Paediatric Development Plans

The European Medicines Agency and the US Food and Drug Administration recently published a common commentary document on paediatric oncology drug development, building on the call for simultaneous submissions of paediatric investigation plans and initial pediatric study plans. The objective of this...

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Bibliographic Details
Published inTherapeutic innovation & regulatory science Vol. 55; no. 6; pp. 1109 - 1110
Main Authors Karres, Dominik, Reaman, Gregory, Ligas, Franca, Lesa, Giovanni, McCune, Susan, Malli, Suzanne, Bax, Ralph, Temeck, Jean
Format Journal Article
LanguageEnglish
Published Cham Springer International Publishing 01.11.2021
Springer Nature B.V
Subjects
Commentary
Coordination
Drug development
Drug Safety and Pharmacovigilance
Medicine
Oncology
Pediatrics
Pharmacotherapy
Pharmacy
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Summary:The European Medicines Agency and the US Food and Drug Administration recently published a common commentary document on paediatric oncology drug development, building on the call for simultaneous submissions of paediatric investigation plans and initial pediatric study plans. The objective of this document is to guide deliberations and permit focused discussions at the monthly paediatric cluster calls, allowing early regulatory coordination of global development plans. The differences in regulations related to timeline are not considered posing a barrier in that regard.
Bibliography:ObjectType-Article-1
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ISSN:2168-4790
2168-4804
DOI:10.1007/s43441-021-00339-z